ALBERT

Beschreibung: Introduction The ASH Annual Meeting is a venue for presentation of outcomes data from key clinical trials in hematologic malignancies and novel drug classes used to treat them. The approval of two CAR-T therapies, axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel), in the treatment of large B-cell lymphoma (LBCL), including diffuse LBCL (DLBCL), has ushered in a new class of drugs, i.e. cellular therapy. At ASH 2018, Nastoupil et al. presented data from a retrospective analysis of the characteristics and outcomes of patients with relapsed/refractory LBCL, including DLBCL, treated with commercially available axi-cel CAR-T therapy at academic centers in the United States (Nastoupil LJ, et al. Blood. 2018;132[Suppl 1]:91). The authors found that early outcomes of real-world patients receiving axi-cel therapy were comparable to those observed in the clinical trial population, despite 〉40% of these patients failing to meet the clinical trial eligibility criteria. At a live meeting in February 2019, we sought the perceptions of community hematologists and oncologists (H/O) regarding their use of, referrals for and barriers to CAR-T therapy as well their perception of the value of the real-world evidence (RWE) presented. Methods A live meeting in February 2019 convened H/O with geographic representation from across the United States. The participants were shown data from selected oral and/or poster presentations from the 2018 ASH Annual Meeting and responded to questions regarding their perceptions of the data and its potential impact on current practice. Participants submitted their demographic responses via a web-based survey prior to the meeting and data impression responses via an audience response system at the live meeting. Results Among the 59 H/O who participated in this live market research program on February 22-23, 2019, 61% identified their primary specialty as hematology/oncology and 34% medical oncology. Only 27% of H/O had attended the 60th ASH Annual Meeting in December 2018. The participants were mostly community-based physicians, 50% in private community and 45% in community practices owned by a hospital or academic center. One-third have been in practice for over 20 years, one-third for 11-20 years and one-third for 10 or fewer years. This group sees an average of 20+ patients per day and reported B-cell non-Hodgkin lymphoma as one of the three most common hematologic malignancy they managed. 28% of H/O indicated that they have referred one patient and 24% have referred 2-5 patients for CAR-T therapy since the first approval on August 30, 2017. Of those H/O who had referred patients for CAR-T therapy, 45% indicated that none of their patients had yet received the infusion. The top two barriers to prescribing/recommending CAR-T therapy, as reported by the H/O, were the cumbersome logistics of administering therapy and following patients (52%), and the cost of the therapy (46%). Other concerns included high toxicity (24%) and lack of long-term survival data (19%), but not lack of knowledge of CAR-T therapy (2%). Furthermore, 87% of H/O agreed with the assertion that due to the limitations of randomized clinical trials, RWE is necessary to inform clinical practice. After review of the information presented on the real-world use of axi-cel, 73% of H/O indicated that this information is likely to cause them to recommend CAR-T therapy for more of their patients with DLBCL. Conclusions There is significant interest in adopting and using CAR-T therapies in LBCL amongst community H/O. This group does not perceive itself as lacking in knowledge regarding CAR-T therapy. The significant barriers of logistics and cost are potential deterrents to appropriate use. These results can inform stakeholders (manufacturers, payers, hospitals and practices) regarding the need to improve processes and develop payment models to address cost in order to facilitate access of these agents to the appropriate patients. RWE is viewed favorably by the vast majority of community H/O to inform clinical practice, due to the limitations of randomized clinical trials. Disclosures Gajra: Cardinal Health: Employment. Sweat:Cardinal Health: Employment. Jeune-Smith:Cardinal Health: Employment. Kish:Cardinal Health: Employment. Feinberg:Cardinal Health: Employment.

Beschreibung: Introduction In the past 5 years, four drugs have received approval for the treatment of Chronic lymphocytic leukemia (CLL), with most of the data supporting their approvals presented at an ASH meeting. How treating hematologists and oncologists (H/O) incorporate these agents into their practice has implications for all stakeholders. We conducted market research with H/O to understand how CLL data presented at ASH 2018 might alter their treatment preferences. Methods A live meeting in February 2019 convened H/O. The participants were shown data from selected oral and/or poster presentations from the 2018 ASH Annual Meeting and responded to questions regarding their perceptions on the data and its potential impact on current practice. The presentations used included the following: 1) Alliance A041202: a phase III, randomized study in older patients with untreated CLL comparing ibrutinib ± rituximab with bendamustine + rituximab (BR) (Woyach JA, et al. Blood. 2018;132[Suppl 1]:6); and 2) E1912: a phase III, randomized study in younger patients with untreated CLL comparing ibrutinib + rituximab with fludarabine + cyclophosphamide + rituximab (FCR) (Shanafelt TD, et al. Blood. 2018;132[Suppl 1]:LBA-4). Participants submitted their demographic responses via a web-based survey and data impression responses via an audience response system at the live meeting. Results 59 H/O participated in this live market research on February 22-23, 2019 and identified their primary specialty as 61% hematologist/oncologist and 34% medical oncologist. The participants were mostly community-based physicians, 50% in private community and 45% in community practices owned by a hospital or academic center. Over one-third have been in practice 〉20 years and see an average of 20+ patients per day. In the prior 3 months, 31%, 27%, and 18% of the participants initiated first-line treatment on 1, 2, or 3 CLL patients, respectively. The most commonly preferred first-line treatments for CLL patients ≥65 years without del(17p) were: BR (38%), ibrutinib (34%), anti-CD20 monotherapy (17%), and FCR (7%). Based on the results of the Alliance A041202 trial, 88% are likely to use single-agent ibrutinib as their preferred first-line therapy for older CLL patients, 45% very likely and 43% moderately likely. The most commonly preferred first-line treatments for CLL patients

Beschreibung: Introduction There has been a remarkable growth of new therapies for multiple myeloma (MM) in the last 5 years with 5 new agents approved by the FDA. Daratumumab is a human anti-CD38 monoclonal antibody previously approved as a single agent in relapsed/refractory (RR) MM and as combination in relapsed MM. Selinexor represents a novel first-in-class selective inhibitor of nuclear export (SINE) XPO1 antagonist in RRMM. The perception of practicing community hematologists and oncologists (H/O) regarding new information presented at major scientific meetings has implications for all stakeholders including patients, practices, payers, manufacturers and distributors. We conducted market research with H/O to understand how MM data presented at ASH 2018 and ASCO 2019 might alter their treatment preferences. Methods Live meetings in February and June 2019 convened H/O with geographic representations from across the United States. The participants were shown data from selected oral and/or poster presentations from the 2018 ASH Annual Meeting or 2019 ASCO Annual Meeting and responded to questions regarding their perceptions of the data and its potential impact on current practice. The presentations used included the following: 1) MAIA: a phase III, randomized study in patients with transplant-ineligible newly diagnosed MM (NDMM) comparing daratumumab plus lenalidomide and dexamethasone (D-Rd) to lenalidomide and dexamethasone (Rd) alone (Facon T, et al. Blood. 2018;132[Suppl 1]:LBA-2); 2) CASSIOPEIA: a phase III, randomized study in patients with transplant-eligible NDMM comparing daratumumab plus bortezomib, thalidomide and dexamethasone (D-VTd) to bortezomib, thalidomide and dexamethasone (VTd) alone (Moreau P, et al. J Clin Oncol. 2019;37[15_suppl]:8003); and 3) STORM: a pivotal, phase II, single-arm study of selinexor and dexamethasone in patients with penta-refractory MM (Chari A, et al. Blood. 2018;132[Suppl 1]:598). Participants submitted their demographic responses via a web-based survey prior to the meetings and data impression responses via an audience response system at the live meetings. Results Among the 112 H/O who participated in these live market research programs on February 22-23 and June 21-22, 2019, 58% identified their primary specialty as hematology/oncology and 38% medical oncology. Only 27% of the 59 H/O at the February live meeting had attended the ASH 2018 in December 2018 and 43% of the 53 at the June live meeting had attended the ASCO 2019 in June 2019. The participants were mostly community-based physicians, 47% in private community and 48% in community practices owned by a hospital or academic center. 31% have been in practice for over 20 years, 39% for 11-20 years and 29% for 10 or fewer years. The majority of this group sees at least 16 patients per day and reported active MM as one of the three most common hematologic malignancies they manage. At the February 2019 live meeting, 79% of H/O in attendance indicated that, based on the results of the MAIA study, D-Rd is likely to become their standard of care for patients with NDMM who are ineligible for transplant. At the June 2019 live meeting, the majority of H/O in attendance indicated that bortezomib + lenalidomide + dexamethasone (VRd) was the regimen typically used for their transplant-eligible NDMM patients. After reviewing the data from the CASSIOPEIA study of D-VTd, 50% of H/O indicated that the results are practice-changing and will be widely adopted, but thalidomide will be substituted with lenalidomide (D-VRd). 65% of H/O who attended the February 2019 live meeting indicated that, if selinexor is approved by the FDA, they are very likely to consider it for their patients with RRMM. 76% of advisors indicated that selinexor's novel mechanism of action (MOA) is very clinically meaningful in MM. Qualitative data collected also denotes interest in seeing selinexor tested and moved to earlier lines of therapy akin to the development course followed by daratumumab. Conclusions The movement of daratumumab to the first-line setting was well received by the community H/O and their willingness to substitute IMiD drugs in the backbone regimen for transplant-eligible patients was notable. It is noteworthy that the interest in selinexor was high even prior to its FDA approval and especially driven by its novel MOA. Disclosures Gajra: Cardinal Health: Employment. Sweat:Cardinal Health: Employment. Jeune-Smith:Cardinal Health: Employment. Feinberg:Cardinal Health: Employment.

Beschreibung: Introduction: In this era of targeted therapy, assessing MRD status is important to guide treatment decision-making in hematologic malignancies. While MRD assessment has long been incorporated the management of patients with acute lymphoblastic leukemia (ALL), there is mounting evidence that MRD-negativity is a critical end point in CLL and MM that correlates well with clinical outcomes. In CLL, undetectable MRD at the end of treatment in peripheral blood or bone marrow is associated with long-term survival (Thompson et al, Leukemia 2018). The international workshop on CLL (iwCLL) guidelines for response assessment in CLL now incorporate MRD assessment (Hallek, et al, Blood 2018). The international myeloma working group (IMWG) and the NCCN now recommend MRD assessment after each phase of MM therapy (induction, stem cell transplant, consolidation and maintenance). Higher rates of durable responses are noted in those with MRD-negativity after induction (Attal et al, NEJM 2017) and associated with favorable survival (Pavia et a, Blood 2008). Based on results from recent studies, MRD negative status can guide clinical decision-making about discontinuation of therapy in CLL (Jain et al, ASH 209 and Tam et al, ASH 2019) and in MM (Costa et al, ASH 2019 and Usmani et al, 2019). A majority of patients with CLL and MM are treated at community practices in the US. but adoption of MRD assessment among cH/O is unclear. We sought to study the self-reported utilization patterns of MRD assessment in CLL and MM, it's use in determining duration of therapy, and the barriers to it's adoption in practice among U.S. cH/O. Methods: U.S.-licensed oncologists and hematologists with broad geographic representation convened at a live meeting in January 2020 to review clinical updates presented at the 2019 ASH Annual Meeting. An electronic pre-meeting survey and live survey were fielded among cH/O meeting attendees. Surveys collected physician perceptions and reported use of MRD assessment for patients with CLL and MM. Responses to questions were summarized using descriptive statistics. Results: A total of 59 cH/O were included who self-identified their specialty as hematology/ oncology (51%) and medical oncology (34%) and reported MM (69%) and CLL (61%) as the two commonest hematologic malignancies treated by them. Excluding those that had not treated MM or CLL in the preceding 3 months, a subset of 46 cH/O were queried on their use and perceptions of MRD assessment in these two diseases. In CLL, 52% of the cH/O do not assess MRD status, and only 17% utilize MRD status in treatment discontinuation decisions. Major reasons for not using MRD status in practice include the perception shared by a majority (52%) of respondents that the evidence does not support its use in CLL at the present time. A minority (9%) utilized MRD assessment when treating younger fit patients with CLL. In MM, 50% do not assess for MRD at any time post-therapy, and 24% utilize MRD status in treatment discontinuation decisions. Major barriers to MRD assessment in MM were the perception that evidence does not support MRD use (59% of the respondents) and lack of payer coverage (11%). Additional details are presented in the Table below. Conclusions: These data from a limited sample of cH/O suggest that adoption of MRD testing among US cH/O is low, despite results from recent trials that highlight the importance of the MRD negativity as an important prognostic factor in both CLL and MM. Half of cH/O do not measure MRD at any point while treating MM and CLL and less than a fifth incorporate MRD data to determine duration of therapy. The greatest barrier to MRD assessment is the impression that there is lack of evidence supporting its utility in practice at the present time. Further education among cH/O is warranted regarding MRD assessment in CLL and MM given that MRD-negative status is associated with favorable prognosis and should be incorporated in treatment decision-making based on updated guidelines in both diseases. Disclosures Gajra: Cardinal Health: Current Employment. Jeune-Smith:Cardinal Health: Current Employment. Klink:Cardinal Health: Current Employment. Feinberg:Cardinal Health: Current Employment.

Beschreibung: Introduction: Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are chimeric antigen receptor T-cell (CAR-T) therapies approved in the United States (US) for the treatment of relapsed or refractory large B-cell lymphoma (R/R LBCL). Almost half of all patients with cancer are treated in community-based oncology practices in the US. Understanding the adoption of novel therapies by community hematologists/oncologists (cH/O) is critical to assessing their future utilization and impact on clinical outcomes. We sought to study the temporal trends of CAR-T utilization over a year among cH/O and their perceptions regarding the barriers to adoption of CAR-T therapies in R/R LBCL in a descriptive study using survey-based methodology. Methods: Live meetings held in February 2019 (cohort A) and Winter 2020 (November 2019-February 2020, cohort B) convened cH/O of diverse US regions and practice types to better understand perceptions around CAR-T, its utilization in R/R LBCL, and referral patterns. Participants were compensated for participation and submitted responses via web-based pre-meeting surveys and live audience response system. All responses are summarized using descriptive statistics. A subset analysis was performed for the cH/O who were surveyed in both cohort A and cohort B. Results: A total of 59 and 168 cH/O participated in this research study in cohorts A and B, respectively: 61% and 70% of participants identified their primary specialty as hematology/oncology; in a private community practice (50% and 56%), or community practice owned by a hospital or academic center (44% and 24%, p=.003). Both groups reported seeing an average of 〉20 patients per day. The proportion of cH/O who indicated that they had referred at least one patient for CAR-T therapy for R/R LBCL in the preceding 6 months was 54% and 93% (p